NCT00468546 · FLOW

Participant flow

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
id
FG000
title
Placebo Plus Methotrexate
description
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
id
FG001
title
Rituximab Plus Methotrexate

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
83
group Id
FG001
num Subjects
37
type
Lack of Efficacy
reasons
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
5
type
Refused treatment
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
8
type
Adverse Event
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
4
type
Failure to return
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
0
type
Rescue therapy
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Incorrect diagnosis and treatment
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Due to clinical hold
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Went onto rescue therapy
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Participant unblinded (clinical hold)
milestones
achievements
group Id
FG000
num Subjects
208
group Id
FG001
num Subjects
308
type
STARTED
achievements
group Id
FG000
num Subjects
111
group Id
FG001
num Subjects
253
type
COMPLETED
achievements
group Id
FG000
num Subjects
97
group Id
FG001
num Subjects
55
type
NOT COMPLETED
title
Week 24 Analysis
drop Withdraws
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
5
type
Adverse Event
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Death
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
12
type
Lack of Efficacy
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
2
type
Protocol Violation
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
7
type
Refused treatment
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
2
type
Failure to return
reasons
group Id
FG000
num Subjects
77
group Id
FG001
num Subjects
183
type
Movement into re-treatment study
reasons
group Id
FG000
num Subjects
17
group Id
FG001
num Subjects
14
type
Other
milestones
achievements
comment
Participants who completed/not completed Week (W) 24 analysis were entered in W24 to W104 analysis.
group Id
FG000
num Subjects
208
comment
Participants who completed/not completed W24 analysis were entered in W24 to W104 analysis.
group Id
FG001
num Subjects
308
type
STARTED
achievements
group Id
FG000
num Subjects
103
group Id
FG001
num Subjects
83
type
COMPLETED
achievements
group Id
FG000
num Subjects
105
group Id
FG001
num Subjects
225
type
NOT COMPLETED
title
Week 24 to Week 104 Analysis

pre Assignment Details

Of the total randomized 520 participants who met the eligibility criteria, four did not receive the study treatment and were not included in any analysis population.

recruitment Details

A total of 520 participants were enrolled in the study conducted from 02 May 2003 and 12 July 2012 in 11 countries.

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